510(k) Report

FDA applicant

Precision-Cosmet Co., Inc.

Minnetonka, MN4 decisions1984–19860 recalls

FDA records 4 decisions for Precision-Cosmet Co., Inc. (Minnetonka, MN) from 1984 to 1986: 4 510(k) clearances. Most are in product codes KYB (Lens, Guide, Intraocular) and HNR (Forceps, Ophthalmic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Precision-Cosmet Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision-Cosmet Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Precision-Cosmet Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KYBLens, Guide, Intraocular1decision
  • HNRForceps, Ophthalmic1decision
  • KYFImplant, Eye Valve1decision
  • HNYCystotome1decision

What has FDA decided for it lately?

  • K861057Manual Ophthalmic Surgical InstrumentsPrecision-Cosmet Co., Inc. · 1986
  • K852934Precision - Cosmet Capsule CoupeurPrecision-Cosmet Co., Inc. · 1985
  • K840204White Ocular Pressure Relief DevicePrecision-Cosmet Co., Inc. · 1985
  • K840104Petrus Iol GuidePrecision-Cosmet Co., Inc. · 1984

All 4 as Precision-Cosmet Co., Inc. →